Comparison of Sevoflurane and Propofol on ANI | NCT06907823

Studies
Comparison of Sevoflurane and Propofol on ANI

NCT06907823

Sponsor

Pusan National University Yangsan Hospital

Status

Not yet recruiting

Last Update Posted

Jun 10, 2025Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Propofol
Sevoflurane
Analgesia Nociception Index

Interventions

propofol
Sevoflurane

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2025Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Mar 28, 2025

First Submission Date that Met QC Criteria

Mar 31, 2025

First Posted Date

Apr 2, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2025

Last Update Posted Date

Jun 10, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jimin Lee, Clinical professor, Pusan National University Yangsan HospitalPrincipal Investigator

Lead Sponsor

Pusan National University Yangsan HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to compare the effect of sevoflurane and propofol on analgesia nociception index(ANI) in patients undergoing general anesthesia. The main question it aims to answer is whether propofol anesthesia results in lesser ANI change to a nociceptive stimulation compared to sevoflurane.

Detailed Description

Patients will be allocated to either propofol or sevoflurane group. Nociceptive event will be defined as long-lasting tetanic stimulation, square-wave, duration of 30 seconds , amplitude of 50mA, frequency of 50 Hz. analgesia nociception index value and hemodynamic parameters will be recorded 1-minute before and after nociceptive event.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sevoflurane	Other		Drug: Sevoflurane
Propofol	Other		Drug: propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
propofol	Drug	propofol anesthesia	Propofol
Sevoflurane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
analgesia nociception index change	analgesia nociception index value 1-minute before tetanic stimulation and 1-minute after tetanic stimulation	During anesthesia period

Secondary Outcomes

Measure	Description	Time Frame
Hemodynamic change	Blood pressure change 1 minute before tetanic stimuation and 1 minute after tetanic stimulation	During anesthesia period
Hemodynamic change	Heart rate change before 1-minute before nociceptive stimuli and 1-minute after nociceptive stimuli

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American society of anesthesiologists physical status class I or II

Exclusion Criteria:

history of drugs that can affect the central nervous system and autonomic nervous system, such as anticholinergics, betablockers, antidepressants..etc.
history of allergic reaction to sevoflurane and/or propofol
history of and/or family history of malignant hyperthermia
neurodegenerative disorder
psychiatric disorder
arrhythmia
diabetes mellitus
drug abuse history

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol
D000077149	Sevoflurane

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

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Browse Branches

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